Journal of Cystic Fibrosis
Volume 8, Issue 6 , Pages 370-377 , December 2009

Efficacy and safety of Creon® 24,000 in subjects with exocrine pancreatic insufficiency due to cystic fibrosis

  • Bruce C. Trapnell

      Affiliations

    • Divisions of Pulmonary Biology and Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, and Division of Pulmonary, Sleep, and Critical Care Medicine, University of Cincinnati, 3333 Burnet Avenue, Cincinnati, OH, 45229-3039, USA
    • Corresponding Author InformationCorresponding author. University of Cincinnati, Cincinnati Children's Hospital Medical Center, Divisions of Pulmonary Biology and Pulmonary Medicine, and Division of Pulmonary, Sleep, and Critical Care Medicine, 3333 Burnet Avenue, Cincinnati, OH 45229. Tel.: (513) 6366361; fax: (513) 6363723.
    • ,
  • Karen Maguiness

      Affiliations

    • Section of Pediatric Pulmonology, Indiana University School of Medicine, 702 Barnhill Drive, ROC Room 4270, Indianapolis, IN, 46202, USA
    • ,
  • Gavin R. Graff

      Affiliations

    • Department of Pediatrics, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, 500 University Drive, PO Box 850, Hershey, PA, 17033-0850, USA
    • ,
  • David Boyd

      Affiliations

    • Solvay Pharmaceuticals, Inc., 1800 Parkway Place, Parkway Center, P1-3047, Marietta, GA, 30067, USA
    • ,
  • Katrin Beckmann

      Affiliations

    • Solvay Pharmaceuticals GmbH, Hans-Böckler-Allee 20, 30173 Hannover, Germany
    • ,
  • Steven Caras

      Affiliations

    • Solvay Pharmaceuticals, Inc., 1800 Parkway Place, Parkway Center, P1-3047, Marietta, GA, 30067, USA

Received 22 April 2009 ,Revised 20 August 2009 ,Accepted 21 August 2009.

References 

  1. Walkowiak J, Sands D, Nowakowska A, Piotrowski R, Zybert K, Herzig KH, et al. Early decline of pancreatic function in cystic fibrosis patients with class 1 or 2 CFTR mutations. J Pediatr Gastroenterol Nutr. 2005;40:199–201
  2. Ferrone M, Raimondo M, Scolapio JS. Pancreatic enzyme pharmacotherapy. Pharmacotherapy. 2007;27:910–920
  3. Baker SS, Borowitz D, Baker RD. Pancreatic exocrine function in patients with cystic fibrosis. Curr Gastroenterol Rep. 2005;7:227–233
  4. Wilschanski M. Nutrition in cystic fibrosis. In:  Koletzko B editors. Pediatric Nutrition in Practice. Basel, Switzerland: Karger; 2008;p. 224–228
  5. Safdi M, Bekal PK, Martin S, Saeed ZA, Burton F, Toskes PP. The effects of oral pancreatic enzymes (Creon 10 capsule) on steatorrhea: a multicenter, placebo-controlled, parallel group trial in subjects with chronic pancreatitis. Pancreas. 2006;33:156–162
  6. Sander-Struckmeier S, Boyd D, Caras S. Pancrelipase delayed-release capsules (CREON®): efficacy and safety in children less than 7years old with pancreatic exocrine insufficiency due to cystic fibrosis. Presented at: 21st Annual Meeting of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. November 13–15, 2008;San Diego, CA
  7. Stern RC, Eisenberg JD, Wagener JS, Ahrens R, Rock M, doPico G, et al. A comparison of the efficacy and tolerance of pancrelipase and placebo in the treatment of steatorrhea in cystic fibrosis patients with clinical exocrine pancreatic insufficiency. Am J Gastroenterol. 2000;95:1932–1938
  8. FitzSimmons SC, Burkhart GA, Borowitz D, Grand RJ, Hammerstrom T, Durie PR, et al. High-dose pancreatic enzyme supplements and fibrosing colonopathy in children with cystic fibrosis. New Engl J Med. 1997;336:1283–1289
  9. U.S. Food and Drug Administration. Questions and answers on exocrine pancreatic insufficiency drug products. http://www.fda.gov/CDER/DRUG/infopage/pancreatic_drugs/pancreatic_QA.htm. Published April 27, 2004. Accessed March 9, 2009.
  10. U.S. Food and Drug Administration. FDA requires pancreatic extract manufacturers to submit marketing applications. FDA News. http://www.fda.gov/bbs/topics/news/2004/NEW01058.html. Published April 27, 2004. Accessed 8 August 2008.
  11. U.S. Food and Drug Administration Center for Drug Evaluation and Research. Guidance for Industry: Exocrine Pancreatic Insufficiency Drug Products — Submitting NDAs. http://www.fda.gov/cder/guidance/6275fnl.htm. Published April 13, 2006. Accessed March 9 2009.
  12. Trapnell BC, Maguiness K, Graff GR. Efficacy and safety of a new formulation of CREON® in patients with exocrine pancreatic insufficiency due to CF. J Cystic Fibrosis. 2009;8:S80
  13. Borowitz D, Baker RD, Stallings V. Consensus report on nutrition for pediatric patients with cystic fibrosis. J Pediatr Gastroenterol Nutr. 2002;35:246–259
  14. Sinaasappel M, Stern M, Littlewood J, Wolfe S, Steinkamp G, Heijerman HG, et al. Nutrition in patients with cystic fibrosis: a European Consensus. J Cyst Fibros. 2002;1:51–75
  15. Stallings VA, Stark LJ, Robinson KA, Feranchak AP, Quinton H. Clinical Practice Guidelines on Growth and Nutrition Subcommittee; Ad Hoc Working Group. Evidence-based practice recommendations for nutrition-related management of children and adults with cystic fibrosis and pancreatic insufficiency: results of a systematic review. J Am Diet Assoc. 2008;108:832–839
  16. Borowitz D, Durie PR, Clarke LL, Werlin SL, Taylor CJ, Semler J, et al. Gastrointestinal outcomes and confounders in cystic fibrosis. J Pediatr Gastroenterol Nutr. 2005;41:273–285
  17. Kjeldahl JT. A new method for the determination of nitrogen in organic matter. Z Anal Chem. 1883;22:366–382
  18. Allison DB, Casey DE. Antipsychotic-induced weight gain: a review of the literature. J Clin Psychiatry. 2001;62(Suppl 7):22–31
  19. Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, et al. The Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346:393–403
  20. Borowitz D, Konstan MW, O'Rourke MS, Cohen M, Hendeles L, Murray FT. Coefficients of fat and nitrogen absorption in healthy subjects and individuals with cystic fibrosis. J Pediatr Pharmacol Ther. 2007;12:47–52
  21. Heubi JE, Boas SR, Blake K, Nasr SZ, Woo MS, Graff GR, et al. 246 EUR-1008 (a new pancreatic enzyme product, PEP) was shown to be safe and effective in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI). J Cystic Fibrosis. 2007;6:S61
  22. Borowitz D, Goss CH, Limauro S, Konstan MW, Blake K, Casey S, et al. Study of a novel pancreatic enzyme replacement therapy in pancreatic insufficient subjects with cystic fibrosis. J Pediatr. 2006;149:658–662
  23. Kuhn RJ, Eyting S, Henniges F, Potthoff A. In vitro comparison of physical parameters, enzyme activity, acid resistance, and pH dissolution characteristics of enteric-coated pancreatic enzyme preparations: implications for clinical variability and pharmacy substitution. J Pediatr Pharmacol Ther. 2007;12:115–128

☆ Previously presented at Digestive Disease Week, May 30–Jun 04, 2009, Chicago, IL, USA, and the 32nd European Cystic Fibrosis Society Conference, June 10–13, 2009, Brest, France.

PII: S1569-1993(09)00122-2

doi: 10.1016/j.jcf.2009.08.008

Journal of Cystic Fibrosis
Volume 8, Issue 6 , Pages 370-377 , December 2009

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